Efficacy Evaluation Of Skin Fairness Creams On Healthy Human Volunteers

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/11/002134

Enrollment

320

Registered

2011-11-16

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Fairness Cream A Fairness Cream B Fairness Cream c Fairness Cream D Fairness Cream E Fairness Cream F Fairness Cream G Fairness Cream H : All these Investigational products are cosmeceu

Eligibility

Inclusion criteria

Inclusion criteria: Subjects willing to give a written informed consent and come for regular follow up. Female subjects in generally good health, in the age group of 18 - 45 years. Subjects having Chromameter L value between 40-60 on cheeks and L value at least 3 units higher than the cheeks on upper volar bicep region. Subject, who get Sun exposure for atleast 20-40 mins per day. At least 5 subjects under each treatment group having acne prone skin. At least 5 subjects under each treatment group having few hyper-pigmentation spots on face like solar lentigines and /or post acne dark spots other than melasma/ nevi etc. Subjects willing to abstain from using other cosmetic/ medicinal/ ayurvedic/ natural products on face during the study course.

Exclusion criteria

Exclusion criteria: A known history or present condition of Allergic response to any cosmetic product Subject having skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations), which would interfere with the test readings Subjects having Melasma/ Chloasma/ Nevi/ Post inflammatory hyperpigmentation marks and other forms of severe photo damage at the site of evaluation (Except Hyper-pigmentary age spots/ small post acne marks) Subjects on medications (e.g. steroids or antihistamines), which could compromise the study results Pregnant/ nursing females Subjects who are involved in physical labor work Subjects with tattoos, dense hair, moles, warts on face and volar forearms at the site of evaluation. Subjects with known sensitivity to sun, sunscreens/ cosmetics/ fragrances Subjects having participated in a similar investigation in the past four weeks Subjects having used a similar product for the last two weeks (Washout period)

Design outcomes

Primary

Measure	Time frame
1)To evaluate the efficacy of fairness cream formulations in conferring skin fairness, radiance and glow, moisturization, softness, smoothness and healthy appearance in comparison to baseline and to other investigational products.2)To evaluate the efficacy of fairness cream formulations in reducing Sun induced tanning and associated photodamage in terms of dark spots and wrinkling in comparison to baseline and to other investigational products.Timepoint: 6 Weeks	—

Measure

Time frame

1)To evaluate the efficacy of fairness cream formulations in conferring skin fairness, radiance and glow, moisturization, softness, smoothness and healthy appearance in comparison to baseline and to other investigational products.2)To evaluate the efficacy of fairness cream formulations in reducing Sun induced tanning and associated photodamage in terms of dark spots and wrinkling in comparison to baseline and to other investigational products.Timepoint: 6 Weeks

—

Secondary

Measure	Time frame
? To evaluate the safety of fairness cream formulations on all skin types including acne prone skin. ? To evaluate the efficacy of fairness cream formulations in conferring even tone, clear skin, young appearing skin in comparison to baseline, placebo and other investigational products.Timepoint: 6 Weeks	—

Countries

India

Contacts

Public ContactDr Mukta Sachdev

MS CLINICAL RESEARCH PVT. LTD

mukta.sachdev@mscr.in918040917253

Outcome results